Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by McMaster University
Sponsor:
Collaborator:
Janssen-Ortho Inc., Canada
Information provided by (Responsible Party):
M. Van Ameringen, McMaster University
ClinicalTrials.gov Identifier:
NCT00182520
First received: September 14, 2005
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment.


Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: Topiramate
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Improvement ≤ 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PI-SWUR Hoarding Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Self Report Y-BOCS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2002
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topiramate
Drug: Topiramate
25 mg - 400 mg/day x 12 weeks
Other Name: Topomax
Placebo Comparator: 2
placebo
Drug: placebo
25 - 400 mg/day x 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient with primary DSM- IV OCD
  • Completion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of < 35%)
  • Stable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.

Exclusion Criteria:

  • Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.
  • A previous adequate trial of topiramate
  • Comorbid major depressive disorder diagnosis which predates OCD diagnosis
  • Cognitive behavioural therapy or additional psychotherapy in past four months
  • Allergy or hypersensitivity to topiramate
  • BMI < 20
  • History of kidney stones
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182520

Contacts
Contact: Beth E Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca

Locations
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd    905-921-7644    bpatter@mcmaster.ca   
Sub-Investigator: Catherine Mancini, MD, FRCPC         
Sub-Investigator: Steve Collins, MB, FRCPC         
Sub-Investigator: Jonathan Oakman, PhD         
Principal Investigator: Michael Van Ameringen, MD, FRCPC         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Janssen-Ortho Inc., Canada
Investigators
Principal Investigator: Michael VanAmeringen, MD, FRCPC McMaster University
  More Information

No publications provided

Responsible Party: M. Van Ameringen, Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University
ClinicalTrials.gov Identifier: NCT00182520     History of Changes
Other Study ID Numbers: 01-133
Study First Received: September 14, 2005
Last Updated: March 4, 2013
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Treatment Refractory Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Topiramate
Serotonin Uptake Inhibitors
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on October 01, 2014